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Siemens Healthineers, Roche Diagnostics, Thermo Fisher Scientific, Others Nab FDA Clearances in July

NEW YORK ─ The US Food and Drug Administration granted 510(k) clearances for tests from Siemens Healthineers, Roche Diagnostics, Thermo Fisher Scientific, BioMérieux, and others in July, according to the agency's website.

The FDA greenlighted four tests for Siemens Healthineers, including the Advia Chemistry Enzymatic Hemoglobin Ale (AlcE) assay which measures hemoglobin A1c to diagnose diabetes mellitus; monitor long-term blood glucose control in patients with diabetes mellitus; and identify patients at risk for developing diabetes mellitus.

The Erlangen, Germany-based firm also obtained clearance for the Advia Centaur Total hCG assay, which is used for the quantitative measurement of human chorionic gonadotropin for the early detection of pregnancy. The test is for use with the Advia Centaur XP system.

The FDA further granted the company clearance for its N Latex FLC kappa and lambda diagnostic reagents to detect kappa or lambda free light chains in serum and plasma. The reagents are used to diagnose and monitor multiple myeloma on the Siemens Healthineers BN Systems and Atellica CH analyzers; to diagnose amyloidosis on the same analyzers; and to evaluate monoclonal gammopathy of undetermined significance on the BN Systems analyzer.

Siemens Healthineers obtained a fourth clearance for its Advia Centaur Digoxin assay, which measures digoxin in serum and plasma using its Advia Centaur XP systems. Digoxin is used to treat heart failure, usually along with other medications.

The FDA granted clearance to Basel, Switzerland-based Roche Diagnostics for its Elecsys Syphilis immunoassay which detects total lgG and IgM antibodies to Treponema pallidum in serum and plasma. The test is used to diagnose syphilis infection while running on Roche's Cobas e immunoassay analyzers. It should not be used to screen blood or tissue donors, the FDA said.

Marcy-l'Étoile, France-based BioMérieux obtained 510(k) clearance for its Vitek 2 AST-Gram Negative Meropenem assay for antimicrobial susceptibility testing of Gram-negative bacilli while running on the company's Vitek 2 and Vitek 2 Compact systems. The antibiotic meropenem is used to treat bacterial infections.

The FDA also granted clearance to Waltham, Massachusetts-based Thermo Fisher Scientific for its Phadia EliA SmDP-S fluoroimmunoassay for the semi-quantitative measurement of IgG Smith antibodies to diagnose systemic lupus erythematosus.

The company also obtained clearance for its Sensititre 20- to 24-hour Haemophilus influenzae/Streptococcus pneumoniae Minimum Inhibitory Concentration (MIC) or Breakpoint Susceptibility System with Dtest for the antibiotics erythromycin and clindamycin.

It further obtained clearance for the Thermo Scientific Oxoid Antimicrobial Susceptibility Test to determine the susceptibility of a number of Gram-negative bacteria to cefiderocol (Shionogi's Fetroja).

Brea, California-based Beckman Coulter obtained clearance for its iQ200, an automated urine microscopy system that provides a complete urinalysis profile. The system includes a urine test strip chemistry panel and microscopic sediment analysis. Simultaneously, the firm obtained clearance for its iChemVelocity Automated Urine Chemistry System, which automatically provides a chemistry analysis profile using iChemVelocity urine chemistry strips. The automated urine chemistry system is used to diagnose metabolic disorders, including kidney function anomalies, urinary tract infections, and liver function.

In other July clearances, Chelmsford, Massachusetts-based First Light Diagnostics obtained the green light for its SensiTox C. difficile Toxin Test on its MultiPath Analyzer, which detects Clostridioides difficile toxins A and B via single molecule counting. New York-based NYU Langone Health got the nod for its Genome PACT genetic test for solid tumors. And Madison, Wisconsin-based Promega obtained clearance for its OncoMate MSI Dx Analysis System, a microsatellite instability diagnostic test to screen for Lynch syndrome in colorectal cancer patients.